Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence/Burden of Postoperative Atrial Fibrillation
研究概览
简要总结
In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)
排除标准
- •Patients >90 or <40 years of age
- •Chronic atrial fibrillation
- •Prior splenectomy
- •Preoperative inotropic support
- •Hepatic or renal failure
- •Currently receiving vagal nerve stimulation therapy
- •Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine)
- •High-grade atrioventricular block (>2nd degree atrioventricular blockade)
结局指标
主要结局
Incidence/Burden of Postoperative Atrial Fibrillation
时间窗: Inpatient hospitalization approximately 3 to 7 days
次要结局
- Serologic Markers of Inflammation(Inpatient hospitalization approximately 3 to 7 days)
- Postoperative mortality(Inpatient hospitalization approximately 3 to 7 days, and one year after surgery)
- Postoperative morbidity(Inpatient hospitalization approximately 3 to 7 days, and one year after surgery)